UA87836C2 - METHOD OF OBTAINING PURE, SAFETY FROM THE VIRUSOLOGICAL POINT OF VIEW OF ANTIBODIES - Google Patents
METHOD OF OBTAINING PURE, SAFETY FROM THE VIRUSOLOGICAL POINT OF VIEW OF ANTIBODIESInfo
- Publication number
- UA87836C2 UA87836C2 UAA200610282A UAA200610282A UA87836C2 UA 87836 C2 UA87836 C2 UA 87836C2 UA A200610282 A UAA200610282 A UA A200610282A UA A200610282 A UAA200610282 A UA A200610282A UA 87836 C2 UA87836 C2 UA 87836C2
- Authority
- UA
- Ukraine
- Prior art keywords
- solution
- antibodies
- virus
- resin
- heplanoale
- Prior art date
Links
Classifications
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/06—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies from serum
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/06—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies from serum
- C07K16/065—Purification, fragmentation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
- A61L2/022—Filtration
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
- A61L2/04—Heat
-
- A61L2103/05—
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Organic Chemistry (AREA)
- Epidemiology (AREA)
- Genetics & Genomics (AREA)
- Biochemistry (AREA)
- Biophysics (AREA)
- Medicinal Chemistry (AREA)
- Molecular Biology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Immunology (AREA)
- Peptides Or Proteins (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Micro-Organisms Or Cultivation Processes Thereof (AREA)
Abstract
A method of preparing a purified, virus inactivated and virus safe antibody preparation from a starling solution comprising antibodies and contaminants, the method comprising the steps of: (a) adjusting the pH of the starting solution to about 4.6 to about 4-95 in particular to about 4.8 to about 4.95 to produce an intermediate solution; (b) adding caprylale and/or heplanoale ions to the intermediate solution and maintaining the pH at about 4.6 to about 4.95 in particular pH at about 4.8 to about 4.95, whereby a precipitate is formed and the antibodies are essentially present in the supernatant; (c) incubating the supematant solution under conditions of caprylale and/or heplanoale ion concentration, lime, pH and temperature optionally concentrating and diafiltrating the filtrated solution before pH adjustment; (d) applying the filtered solution with a least one anion exchange resin and optionally with two different anion exchanae resins under conditions that allow binding of contaminants to the resin while not allowing significant binding' of the antibodies to the resin, wherein a purified, virus inactivated and virus safe antibody preparation is produced.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US54810704P | 2004-02-27 | 2004-02-27 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| UA87836C2 true UA87836C2 (en) | 2009-08-25 |
Family
ID=34910983
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| UAA200610282A UA87836C2 (en) | 2004-02-27 | 2005-02-25 | METHOD OF OBTAINING PURE, SAFETY FROM THE VIRUSOLOGICAL POINT OF VIEW OF ANTIBODIES |
Country Status (18)
| Country | Link |
|---|---|
| US (1) | US7553938B2 (en) |
| EP (2) | EP1718675B2 (en) |
| JP (1) | JP5042817B2 (en) |
| KR (1) | KR101206788B1 (en) |
| CN (1) | CN1922207B (en) |
| AU (1) | AU2005217148B2 (en) |
| BR (1) | BRPI0508096B8 (en) |
| CA (1) | CA2557229C (en) |
| DK (1) | DK1718675T3 (en) |
| ES (1) | ES2407380T5 (en) |
| IL (1) | IL177541A (en) |
| NO (1) | NO20063784L (en) |
| PL (1) | PL1718675T3 (en) |
| PT (1) | PT1718675E (en) |
| RU (1) | RU2337109C2 (en) |
| UA (1) | UA87836C2 (en) |
| WO (1) | WO2005082937A2 (en) |
| ZA (1) | ZA200607119B (en) |
Families Citing this family (55)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP2069387A4 (en) * | 2006-06-14 | 2011-02-02 | Glaxosmithkline Llc | Methods for purifying antibodies using ceramic hydroxyapatite |
| JP5505853B2 (en) | 2007-02-13 | 2014-05-28 | 味の素株式会社 | Virus inactivation method using slightly acidic arginine as an additive |
| WO2009118331A1 (en) * | 2008-03-28 | 2009-10-01 | Research Foundation For Medical Devices | Method of viral inactivation of biological fluids by solvent/detergent-treatment |
| WO2010138736A2 (en) | 2009-05-27 | 2010-12-02 | Baxter International Inc. | A method to produce a highly concentrated immunoglobulin preparation for subcutaneous use |
| US20130116413A1 (en) * | 2009-12-29 | 2013-05-09 | Dr. Reddy's Laboratories, Inc. | Purification of proteins |
| GB201006753D0 (en) | 2010-04-22 | 2010-06-09 | Biotest Ag | Process for preparing an immunolobulin composition |
| US8796430B2 (en) | 2010-05-26 | 2014-08-05 | Baxter International Inc. | Method to produce an immunoglobulin preparation with improved yield |
| AU2010202125B1 (en) | 2010-05-26 | 2010-09-02 | Takeda Pharmaceutical Company Limited | A method to produce an immunoglobulin preparation with improved yield |
| WO2011150284A2 (en) | 2010-05-26 | 2011-12-01 | Baxter International Inc. | Removal of serine proteases by treatment with finely divided silicon dioxide |
| EP2399613A1 (en) * | 2010-06-22 | 2011-12-28 | Research Foundation For Medical Devices | Fractionation of plasma using caprylic acid |
| WO2012051147A1 (en) * | 2010-10-11 | 2012-04-19 | Abbott Laboratories | Processes for purification of proteins |
| RU2013121589A (en) | 2010-10-13 | 2014-11-20 | Октафарма Аг | METHOD FOR CLEANING THE KEY FACTOR N |
| TR201807926T4 (en) | 2011-02-04 | 2018-06-21 | Octapharma Ag | The method of inactivating / removing coagulation factors by precipitation. |
| FR2977893B1 (en) * | 2011-07-11 | 2015-02-20 | Lab Francais Du Fractionnement | PROCESS FOR PREPARING A CONCENTRATE OF MULTIPURPOSE IMMUNOGLOBULINS |
| CN102286099B (en) * | 2011-08-05 | 2014-04-09 | 深圳市卫光生物制品股份有限公司 | Human cytomegalovirus immunoglobulin for intravenous injection and preparation method thereof |
| TWI629283B (en) | 2012-02-23 | 2018-07-11 | 巴克斯歐塔公司 | Fraction i-iv-1 precipitation of immunoglobins from plasma |
| ES2755056T3 (en) | 2012-02-29 | 2020-04-21 | IgG-stimulated remyelination of peripheral nerves | |
| EP2855504B1 (en) * | 2012-05-31 | 2018-10-24 | Agency For Science, Technology And Research | Chromatographic purification of immunoglobulin g preparations with particles having multimodal functionalities |
| CN102757496B (en) * | 2012-06-07 | 2014-06-18 | 山东泉港药业有限公司 | Method for purifying and preparing anti-VEGF antibody fragment |
| LT2864346T (en) * | 2012-06-21 | 2019-01-25 | Synthon Biopharmaceuticals B.V. | Method of purifying an antibody |
| AU2013205138B2 (en) | 2012-08-09 | 2015-06-25 | Grifols, S.A. | Caprylate Viral Deactivation |
| EP2961763A4 (en) * | 2013-02-28 | 2016-10-12 | Agency Science Tech & Res | CHROMATOGRAPHIC PURIFICATION OF ANTIBODIES FROM CULTIVATED CROPS OF CHROMATIN-DEFICIENT CELLS |
| HK1219964A1 (en) | 2013-03-08 | 2017-04-21 | Genzyme Corporation | Continuous purification of therapeutic proteins |
| KR102114021B1 (en) * | 2013-03-15 | 2020-05-22 | 글락소스미스클라인 인털렉츄얼 프로퍼티 (넘버 2) 리미티드 | Methods for purifying antibodies |
| KR20160068972A (en) | 2013-11-15 | 2016-06-15 | 노파르티스 아게 | Removal of residual cell culture impurities |
| RU2561596C2 (en) * | 2013-12-18 | 2015-08-27 | Федеральное государственное унитарное предприятие "Научно-производственное объединение по медицинским иммунобиологическим препаратам "Микроген" Министерства здравоохранения Российской Федерации | Method for producing virus-inactivated immunoglobulin solutions low in residual caprylic acid |
| TWI709570B (en) | 2014-01-17 | 2020-11-11 | 美商健臻公司 | Sterile chromatography and manufacturing processes |
| TWI709569B (en) | 2014-01-17 | 2020-11-11 | 美商健臻公司 | Sterile chromatography resin and use thereof in manufacturing processes |
| KR20160118369A (en) * | 2014-02-27 | 2016-10-11 | 에이전시 포 사이언스, 테크놀로지 앤드 리서치 | Antibody purification process |
| EP3118210B1 (en) * | 2014-03-11 | 2019-11-13 | Green Cross Holdings Corporation | Method for purifying immunoglobulin |
| EP3842108A1 (en) * | 2014-04-30 | 2021-06-30 | Novo Nordisk A/S | Methods for the purification of proteins using caprylic acid |
| WO2015195452A2 (en) | 2014-06-16 | 2015-12-23 | Emd Millipore Corporation | Single-pass filtration systems and processes |
| WO2015195453A2 (en) | 2014-06-16 | 2015-12-23 | Emd Millipore Corporation | Methods for increasing the capacity of flow-through processes |
| CN115463546A (en) | 2014-06-25 | 2022-12-13 | Emd 密理博公司 | Filter element, tangential flow filtration system, method of producing a feed screen |
| EP3010626B1 (en) | 2014-08-29 | 2022-12-14 | EMD Millipore Corporation | Processes for filtering liquids using single pass tangential flow filtration systems and tangential flow filtration systems with recirculation of retentate |
| KR102079585B1 (en) | 2014-08-29 | 2020-02-21 | 이엠디 밀리포어 코포레이션 | Single pass tangential flow filtration systems and tangential flow filtration systems with recirculation of retentate |
| ES2964640T3 (en) | 2015-08-13 | 2024-04-08 | Amgen Inc | Depth filtration loaded with antigen-binding proteins |
| PT3135687T (en) | 2015-08-31 | 2019-05-21 | Inst Grifols S A | Method for the preparation of immunoglobulins |
| ES2925059T3 (en) | 2016-06-09 | 2022-10-13 | Emd Millipore Corp | Radial path filter elements, systems and methods of use thereof |
| ES2770674T3 (en) | 2016-06-10 | 2020-07-02 | Octapharma Ag | High concentration immunoglobulin composition for pharmaceutical applications |
| IT201600079328A1 (en) * | 2016-07-28 | 2018-01-28 | Altergon Sa | Improved method for the decontamination of biological material by partition and inactivation |
| DK3510042T3 (en) | 2016-09-07 | 2024-06-10 | Glaxosmithkline Ip Dev Ltd | Method for purification of antibodies |
| JP6370853B2 (en) * | 2016-09-26 | 2018-08-08 | インスティトゥト グリフォルス,ソシエダ アノニマ | Method for preparing immunoglobulin |
| RU2708394C2 (en) * | 2016-09-26 | 2019-12-06 | Институто Грифольс,С.А. | Method of producing immunoglobulins |
| AU2019270458B2 (en) | 2018-05-17 | 2026-01-22 | Csl Behring Ag | Method and system of protein extraction |
| EP3843869A1 (en) | 2018-08-31 | 2021-07-07 | Genzyme Corporation | Sterile chromatography resin and use thereof in manufacturing processes |
| CN110627892B (en) * | 2019-09-05 | 2023-04-14 | 江苏康禾生物制药有限公司 | Preparation method of recombinant human thrombopoietic factor stock solution |
| CN110590931B (en) * | 2019-09-05 | 2023-04-07 | 江苏康禾生物制药有限公司 | Method for removing and/or inactivating virus in recombinant human thrombopoietin stock solution |
| MX2022011950A (en) | 2020-03-31 | 2022-10-21 | Takeda Pharmaceuticals Co | METHOD FOR PRODUCING AN IMMUNOGLOBULIN PREPARATION FROM PLASMA WITH REDUCTION OF THE C-1 INHIBITOR. |
| CN111991571B (en) * | 2020-08-12 | 2022-04-05 | 湖州师范学院 | A kind of method of low pH virus inactivation on column |
| JP7606185B2 (en) * | 2020-09-03 | 2024-12-25 | 日機装株式会社 | Phenol red adsorbent and method for removing phenol red |
| EP4271706A4 (en) * | 2020-12-28 | 2025-01-15 | Plasma Technologies LLC | Systems and methods for process scale isolation of immunoglobulin g |
| IL308819A (en) * | 2021-05-26 | 2024-01-01 | Csl Behring Ag | Plasma fractionation by continuous extraction |
| BE1029863B1 (en) * | 2022-05-10 | 2023-05-12 | Prothya Biosolutions Belgium | METHODS FOR PRODUCING IMMUNOGLOBULIN G (IgG) PREPARATIONS AND/OR SOLUTIONS |
| WO2025068923A2 (en) | 2023-09-26 | 2025-04-03 | Takeda Pharmaceutical Company Limited | IMMUNOGLOBULIN FORMULATIONS DEPLETED IN IgA |
Family Cites Families (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| SU836831A1 (en) * | 1978-07-19 | 1982-04-23 | Научно-исследовательский институт эпидемиологии и микробиологии | Method for preparing immunoglobulin preparation |
| CA1201063A (en) | 1982-07-20 | 1986-02-25 | Winnipeg Rh Institute Inc., (The) | Process for preparing purified immune globulin (igg) |
| US4540573A (en) | 1983-07-14 | 1985-09-10 | New York Blood Center, Inc. | Undenatured virus-free biologically active protein derivatives |
| GB8807380D0 (en) | 1988-03-29 | 1988-05-05 | Gunn A | Blood processing apparatus |
| US4939176A (en) | 1988-12-20 | 1990-07-03 | Miles Inc. | Viral inactivation process |
| DE4125625C2 (en) | 1991-08-02 | 1999-12-02 | Octapharma Ag Glarus | Process for the preparation of virus-inactivated immunoglobulin solutions |
| WO1997003706A1 (en) | 1995-07-14 | 1997-02-06 | Croix-Rouge De Belgique | Method and apparatus for inactivating contaminants in blood products |
| US5808011A (en) | 1996-07-01 | 1998-09-15 | Biopure Corporation | Method for chromatographic removal of prions |
| TW491855B (en) | 1996-08-07 | 2002-06-21 | Csl Ltd | Purification of immunoglobulins |
| US5886154A (en) * | 1997-06-20 | 1999-03-23 | Lebing; Wytold R. | Chromatographic method for high yield purification and viral inactivation of antibodies |
| US6281336B1 (en) * | 1998-06-09 | 2001-08-28 | Statens Serum Institut | Process for producing immunoglobulins for intravenous administration and other immunoglobulin products |
| CN1151174C (en) * | 1998-12-21 | 2004-05-26 | 蒋盘宏 | Process for preparing antiglobulin of human lymphocyte |
| US20070244305A1 (en) * | 2004-01-30 | 2007-10-18 | Suomen Punainen Risti Veripalvelu | Process for The Manufacture of Virus Safe Immunoglobulin |
-
2005
- 2005-02-25 UA UAA200610282A patent/UA87836C2/en unknown
- 2005-02-25 JP JP2007500224A patent/JP5042817B2/en not_active Expired - Fee Related
- 2005-02-25 DK DK05716804.9T patent/DK1718675T3/en active
- 2005-02-25 EP EP05716804.9A patent/EP1718675B2/en not_active Expired - Lifetime
- 2005-02-25 US US10/590,900 patent/US7553938B2/en not_active Expired - Lifetime
- 2005-02-25 WO PCT/EP2005/050812 patent/WO2005082937A2/en not_active Ceased
- 2005-02-25 CA CA2557229A patent/CA2557229C/en not_active Expired - Fee Related
- 2005-02-25 PT PT57168049T patent/PT1718675E/en unknown
- 2005-02-25 RU RU2006134285/13A patent/RU2337109C2/en active
- 2005-02-25 AU AU2005217148A patent/AU2005217148B2/en not_active Expired
- 2005-02-25 PL PL05716804T patent/PL1718675T3/en unknown
- 2005-02-25 KR KR1020067019926A patent/KR101206788B1/en not_active Expired - Fee Related
- 2005-02-25 EP EP10179436A patent/EP2277915A1/en not_active Ceased
- 2005-02-25 ES ES05716804.9T patent/ES2407380T5/en not_active Expired - Lifetime
- 2005-02-25 CN CN2005800058459A patent/CN1922207B/en not_active Expired - Lifetime
- 2005-02-25 BR BRPI0508096A patent/BRPI0508096B8/en not_active IP Right Cessation
-
2006
- 2006-08-17 IL IL177541A patent/IL177541A/en active IP Right Grant
- 2006-08-24 NO NO20063784A patent/NO20063784L/en not_active Application Discontinuation
- 2006-08-25 ZA ZA200607119A patent/ZA200607119B/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| AU2005217148A1 (en) | 2005-09-09 |
| EP1718675B2 (en) | 2017-01-25 |
| IL177541A0 (en) | 2006-12-10 |
| DK1718675T3 (en) | 2013-07-15 |
| BRPI0508096B8 (en) | 2021-05-25 |
| EP1718675A2 (en) | 2006-11-08 |
| PT1718675E (en) | 2013-05-21 |
| KR101206788B1 (en) | 2012-11-30 |
| PL1718675T3 (en) | 2013-09-30 |
| IL177541A (en) | 2014-09-30 |
| NO20063784L (en) | 2006-09-25 |
| WO2005082937A3 (en) | 2005-11-17 |
| CA2557229A1 (en) | 2005-09-09 |
| JP5042817B2 (en) | 2012-10-03 |
| EP2277915A1 (en) | 2011-01-26 |
| ES2407380T3 (en) | 2013-06-12 |
| CA2557229C (en) | 2012-07-10 |
| AU2005217148B2 (en) | 2011-09-08 |
| KR20060131920A (en) | 2006-12-20 |
| CN1922207B (en) | 2012-06-06 |
| RU2337109C2 (en) | 2008-10-27 |
| BRPI0508096A (en) | 2007-07-17 |
| CN1922207A (en) | 2007-02-28 |
| RU2006134285A (en) | 2008-04-10 |
| WO2005082937A2 (en) | 2005-09-09 |
| JP2007533660A (en) | 2007-11-22 |
| BRPI0508096B1 (en) | 2019-04-02 |
| US20070173638A1 (en) | 2007-07-26 |
| US7553938B2 (en) | 2009-06-30 |
| EP1718675B1 (en) | 2013-04-10 |
| ZA200607119B (en) | 2007-04-25 |
| ES2407380T5 (en) | 2017-07-07 |
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